Operations Quality Coordinator (m/f/d) in Weil am Rhein, Germany

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Location/Division Specific Information

Fisher Clinical Services GmbH is a subsidiary of Thermo Fisher Scientific with almost 200 employees in Germany and is the market leader in clinical supply chain management services and clinical trial sample manufacturing and logistics for patients worldwide. Further information on the locations in Weil am Rhein and Rheinfelden can be found on our website: www.fisherclinicalservices.com

This is a fixed term position.

A day in the Life:

• Conduct and write formal investigations of process deviations with support of the site staff

• Conducting initial and final risk assessment and assisting with identifying root cause and planning appropriate corrective and preventive actions

• Assist in tracking and evaluating historical data and ensure a timely closure

• In addition to responding to deviations/complaints in a timely manner, the job holder will work with Department Heads and work on processes to proactively identify trends, propose improvements

• Understand and drive strategies to improve quality in the operational department

• Ensure compliance with relevant SOPs in collecting, analyzing and applying of information from internal and external sources to conduct risk assessments

• Gather information from all necessary internal and external sources to assess the impact of the deviation on products already distributed as well as the risk to future operations

• Lead and support investigations in the sales, packaging and other departments

• Identify the most likely root cause(s) and determine appropriate preventive and corrective actions.

• Trend analysis, analysis of investigation data on product complaints and appropriate measures and cooperation with production and quality

• At least 20% of the time is spent observing the distribution/packaging area in order to gather relevant information about the process

• Lead quality improvement processes and drive change in the operations department

• Report on data and improvements in appropriate quality forums

Keys to Success:

Education

• Bachelor”s degree (biology, microbiology, chemistry, pharmacy or similar)

Experience

• Sound relevant experience in a GMP facility.

• A deep understanding of quality aspects and SOPs is an advantage

• Experience with writing deviations and investigations is an advantage

• Advanced writing skills

• Understanding of operational improvement tools

• Knowledge of Kaizen and Continuous Improvement is an advantage

Knowledge, Skills, Abilities

• Excellent knowledge of German and English, both written and spoken

• Strong critical thinking and deductive reasoning skills

• Excellent interpersonal and communication skills (written and oral)

• You must be able to write concisely, meaningfully and descriptively

• Knowledge of systematic root cause analysis methodology

• Understanding of operational improvement tools/PPI

• MS Office skills

• Strong empathy and ability to adapt quickly to new groups

• Reliability, flexibility and ability to work under pressure

• You enjoy working in a team, but can also set and adhere to priorities independently

What we offer:

• Employment with an innovative, future-oriented organisation

• Outstanding career and development prospects

• Company pension scheme and other fringe benefits

• Exciting company culture which stands for integrity, intensity, involvement and innovation

If you are interested, please apply online with your CV and Motivation Letter including possible start date and salary expectations.

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or any other legally protected status.

Apply today! http://jobs.thermofisher.com

Agency notice!

Please note we are not interested in receiving unsolicited CVs from any personnel service providers. Should you choose to send us or upload any such candidate document they will not be acknowledged and will be deleted in line with our privacy policy.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.